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The Use of Bioimpedance to Determine Pre-Clinical Lymphedema in the Post-Operative Breast Cancer Patient

NCT01521000 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 200

Last updated 2012-01-30

No results posted yet for this study

Summary

Primary Objective: To determine whether early intervention (with garment sleeve and gauntlet) in patients with pre-clinical lymphedema can halt the progression of lymphedema.

Secondary Objectives:To evaluate whether bioimpedance is an accurate, reliable method to measure pre-clinical and clinical lymphedema.

Tertiary Objective: To determine whether bioimpedance analysis is better than the gold standard of volume displacement to measure lymphedema.

The successful completion of this study will address whether bioimpedance analysis is a reliable, accurate method to measure pre-clinical and clinical lymphedema. In addition, we intend to evaluate whether bioimpedance analysis is better than the gold standard of volume displacement for measuring lymphedema. And most importantly, we will evaluate whether a short trial of compression garments in women identified to have pre-clinical lymphedema can actually halt the progression of disease. Bryn Mawr Hospital would propose to publish the research and findings of this study, which may have future bearing on the post-operative therapeutic management of subjects with pre-clinical lymphedema following axillary surgery.

Study Design:Randomized, Pilot Study

Conditions

Interventions

DEVICE

Garment Sleeve

compression sleeve (20 to 30 mm of Hg)

Sponsors & Collaborators

  • Sharpe-Strumia Research Foundation

    collaborator OTHER

  • Main Line Health

    lead OTHER

Principal Investigators

  • Andrea V Barrio, MD · Bryn Mawr Hospital

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2010-07-31
Primary Completion
2012-07-31
Completion
2012-12-31

Countries

  • United States

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01521000 on ClinicalTrials.gov